Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects

NCT05858931 | Not Yet Recruiting DMC

• 1 other identifier: XH-23-008
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cesarean section scar defects (CSDs) are one of the long-term complications following cesarean section. They can be detected by transvaginal sonography, hysterosalpingography, sonohysterography and magnetic resonance imaging (MRI). Hysteroscopy is frequently used in evaluating endometrial disease. However, the description of CSDs by hysteroscopy is very limited. Only a few papers about hysteroscopy evaluation have been published. This is an exploratory study to compare hysteroscopic findings with the clinical outcomes of vaginal repair of CSDs.

Conditions

Magnetic Resonance Imaging; Hysteroscopy

Keywords

cesarean section scar defect; hysteroscopy; surgical outcomes

Outcome Measures

Primary Outcomes (4)

• the days of duration of menstruation

  duration of menstruation

  on Days: 1 month

• the days of duration of menstruation

  duration of menstruation

  on Days: 3 month

• the days of duration of menstruation

  duration of menstruation

  on Days: 6 month

• The thickness of the residual myometrium

  The thickness of the residual myometrium

  on Days: 3-6 month

Secondary Outcomes (1)

• number of pregnancy

  3 years

Study Arms (1)

CSD patients

All women suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery.

Procedure: vaginal repair

Interventions

vaginal repair PROCEDURE

vaginal repair

CSD patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage

You may not qualify if:

• Patients who had a history of chronic diseases (such as cerebro-cardiovascular diseases, malignancies and diabetes mellitus), endocrine disorders, menstrual irregularities before cesarean section, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Officials

• Xipeng Wang, Docter

  Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xipeng Wang, Doctor

CONTACT

86-021-25078999; wangxipeng@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share